Moderate Alcohol and Cardiovascular Health Trial

Stopped early · Not applicable

Conditions studied: Cardiovascular Diseases, Diabetes

In brief

The Moderate Alcohol and Cardiovascular Health Trial (MACH15) is a multicenter, worldwide, randomized clinical trial of \~15 gm of alcohol daily versus abstention, using a balanced parallel design and single-blind assessment of all outcomes among approximately 7,800 participants aged 50 years and older with advanced cardiovascular risk. Intervention will average 6 years in duration with a common close-out date. Following recruitment and pre-screening, participants will attend a screening visit followed by a two-week abstention washout period, a baseline visit and randomization, and subsequent visits at 3 months, 6 months, 12 months, and then annually until close-out.

Key facts

Study ID

NCT03169530

Run by

Beth Israel Deaconess Medical Center

People needed

103

Starts

2018-02-05

Expected to finish

2018-06-15

Last updated by the study team

2019-03-15

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥50 years at screening
• Postmenopausal, defined as 12 consecutive months without menstruation
• Not alcohol naïve, defined by having consumed at least one drink of alcohol in the past five years
• High risk for the occurrence of a new cardiovascular disease event, defined as having any one of the following:
• American Heart Association (AHA)/American College of Cardiology (ACC) Risk Score ≥15% within the past 24 months (among those without clinical or subclinical cardiovascular disease [CVD])
• Clinical CVD (more than 6 months prior to randomization), defined by:
• Previous myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG), carotid endarterectomy (CE), carotid stenting;
• Peripheral artery disease (PAD) with revascularization;
• Acute coronary syndrome with or without resting electrocardiogram (ECG) change, ECG changes on a graded exercise test (GXT), or positive cardiac imaging study;
• Prior stroke documented on brain imaging or with a persistent deficit.
• Subclinical CVD, confirmed in available medical records:
• At least a 50% diameter stenosis of a coronary, carotid, or lower extremity artery;
• Coronary artery calcium score ≥400 Agatston units;
• Ankle brachial index (ABI) ≤0.90;
• Left ventricular hypertrophy (LVH) by ECG (based on computer reading), echocardiogram report, or other cardiac imaging procedure report;
• Abdominal aortic aneurysm (AAA) ≥5 cm with or without repair.

You may not qualify if…

• High alcohol consumption, defined by any one of the following:
• Alcohol Use Disorders Identification Test (AUDIT) score >5 at screening
• Drinking, on average, >7 alcoholic beverages/week during the past 6 months
• Drinking 6 or more alcoholic beverages on one occasion during the past 6 months
• Yale-Brown Obsessive Compulsive Scale-heavy drinking (Y-BOCS-hd) total score of ≥6 on questions 7, 8, and 10
• Cardiovascular disease event (MI, revascularization procedure, or stroke) within the 6 months prior to randomization
• AHA Class III-IV heart failure
• History of alcohol or substance abuse (medical record confirmed or self-reported history)
• Other intolerance or allergy to alcohol
• Dual antiplatelet therapy
• History of gastric bypass surgery
• Any serious chronic liver disease (e.g., active hepatitis B and C infections) or liver tests (aspartate aminotransferase [AST], alanine aminotransferase [ALT] and gamma-glutamyl transpeptidase [GGT]) >2 times the upper limit of the normal range using local standards
• Personal history of any colon or liver cancer
• Any other cancer with a life expectancy of less than 3 years
• Diagnosed with breast cancer that required either surgery or removal of breast tissue or chemotherapy
• Mother or sister ever diagnosed with breast cancer that required either surgery or removal of breast tissue or chemotherapy
• Estimated glomerular filtration rate (eGFR) <30 ml/min /1.73m2 or end-stage renal disease (ESRD)
• Ongoing use of any medication for which alcohol consumption is contraindicated
• A Patient Health Questionnaire (PHQ-9) ≥15 at screening
• History of any organ transplant
• Unintentional weight loss >10% in last 6 months
• Currently participating in another clinical trial (intervention trial) with CVD outcomes. Note: Participant must wait until the completion of his/her activities or the completion of the other trial before being screened for MACH15. Local restrictions for entry by participants can be more conservative if mandated.
• Not willing or able to provide a name and contact information for at least one additional contact person other than self
• Investigator discretion regarding appropriateness of participation or concern about intervention adherence, including:
• moderate - severe psychiatric illness

Where it is running

• Johns Hopkins ProHealth Clinical Research Center — Baltimore, Maryland, United States
• Wake Forest Sticht Center on Aging — Winston-Salem, North Carolina, United States
• Julius Clinical — Zeist, Netherlands
• Center for Bioethics and Research — Ibadan, Nigeria

Full record on ClinicalTrials.gov

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